FDA.reportPublic FDA data

NDC 0116-0575 - Hibiclens

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0116-0575
Package NDCs from labels
0116-0575-41, 0116-0575-91, 0116-0575-04, 0116-0575-08, 0116-0575-80, 0116-0575-16, 0116-0575-32
Manufacturer
Xttrium Laboratories, Inc.
Effective date
2025-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hibiclens 4% CHG 4oz Foamer, 4oz, 8oz Foamer, 8oz, 16oz, 32oz 1 gallonXttrium Laboratories, Inc.2025-04-29HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0575HIBICLENS (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]3Unmatched20250519_102afe55-eb58-971b-e063-6394a90ae9b0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 29 of 48 · 942 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEATLANTIC BIOLOGICALS CORP.ec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c2025-05-12Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEAtlantic Biologicals Corps.b445d769-a9e3-f72a-fbab-d485457996d02025-05-12Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
Maokang Alcohol Prep Pad Saturated with 70% Isopropyl AlcoholISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltda13a971c-769a-4909-8980-9e8bec4a03612025-05-09WarningsExact identifier
unii: ND2M416302
ALCOHOL PREP PADS LARGE STERILEISOPROPYL ALCOHOL CLOTHHUZHOU JUNDA INDUSTRY CO., LTD.367ab42b-46fe-90f7-e063-6394a90ad2032025-05-01WarningsExact identifier
unii: ND2M416302
Provon Antimicrobial Foam HandwashCHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.46dd136c-d569-0450-e054-00144ff8d46c2025-04-30WarningsExact identifier
unii: MOR84MUD8E
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.4ab2cfc2-7adb-20c4-e054-00144ff8d46c2025-04-30WarningsExact identifier
unii: MOR84MUD8E
BETASEPTANTISEPTIC SURGICAL SCRUBXttrium Laboratories, Inc.4a6451d7-b347-37ac-e054-00144ff8d46c2025-04-30WarningsExact identifier
unii: MOR84MUD8E
NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3b87bc-d913-6c88-e054-00144ff8d46c2025-04-30Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6e5f9616-ddf5-19c4-e053-2991aa0a372a2025-04-30WarningsExact identifier
unii: MOR84MUD8E
Dyna-Hex 2CHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.0c808ebd-1bf7-175d-e063-6294a90ae7df2025-04-30WarningsExact identifier
unii: MOR84MUD8E
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6e5e678f-3832-d201-e053-2a91aa0a5ea82025-04-30WarningsExact identifier
unii: MOR84MUD8E
Acclean Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATE 0.12% ORAL RINSEXttrium Laboratories, Inc.4a2bd280-918d-0e26-e054-00144ff88e882025-04-30Warnings, Adverse reactionsExact identifier
unii: MOR84MUD8E
33ebd52e-91db-0988-e063-6394a90a0941102afe55-eb58-971b-e063-6394a90ae9b02025-04-29WarningsExact identifier
spl id: 33ebd52e-91db-0988-e063-6394a90a0941
spl set id: 102afe55-eb58-971b-e063-6394a90ae9b0
Germ Attack 70% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375d44e-5af6-8c7f-e063-6394a90abb4b2025-04-25WarningsExact identifier
unii: ND2M416302
Germ Attack 91% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375e0d7-07fa-6489-e063-6294a90a91ec2025-04-25WarningsExact identifier
unii: ND2M416302
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
unii: ND2M416302
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
unii: ND2M416302
Be Smart Get Prepared Alcohol Prep PadISOPROPYL ALCOHOLTotal Resources International, Inc6f2a4cb9-eea9-4894-b774-759f27b6f9a82025-04-14WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC9c85129b-29fa-4393-a9b4-b8ea1ba5be542025-04-14WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.